Regard™
Aami Level 4 Isolation Gown, Pullover, Loop, PE Film, Impervious, NON Streile, 2XL Size
318manufacturers in China registered for this device type
32catalogue numbers in this listing
Who Else Makes It
Concentrated in Hubei (71), Jiangsu (59), Zhejiang (42). 83 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Anqing Kangmingna Packaging Co., Ltd. | Anqing | Anhui | Contract manufacturer | 39 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Taizhou Xinkang Medical Materials Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 35 |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
| Evereast Medical Products Group Co., Ltd. | Changyuan | Henan | Contract manufacturer | 30 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. | Jingmen | Hubei | Contract manufacturer | 23 |
Showing 12 of 318. All 318 manufacturers in China registered for Non-Surgical Gown
Record
| Listed by | Resource Optimization & Innovation, L.L.C. |
|---|---|
| FDA product code | OEA |
| Device type | Non-Surgical Gown |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4040 |
| Premarket notification | Exempt |
| Record published | 2023-01-11 |
| Record revised | 2026-05-01 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Pack of 10, pack of 8, pack of 4, pack of 5, pack of 100, pack of 50 |
| Distribution end date | 2024-11-27 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| CHMG38GNS800XL-REG | 10 | In distribution | |
| CHMG53GNS800L-REG | 10 | In distribution | |
| A4ISOG2XLNS-REG | In distribution | ||
| CHMG53GNSL-REG | 10 | In distribution | |
| CHMG53GNS8002XL-REG | 10 | In distribution | |
| CHMG53GNSXL-REG | 10 | In distribution | |
| A4ISOGULNS-REG | 15 | In distribution | |
| CHMG38GNSXL-REG | 10 | In distribution | |
| CHMG38GNSL-REG | 10 | In distribution | |
| A2ISOGULNS-REG | In distribution | ||
| CHMG38GNS800L-REG | 10 | In distribution | |
| CHMG38GNS2XL-REG | 10 | In distribution | |
| A2ISOGXLNS-REG | In distribution | ||
| A2ISOG3XLNS-REG | In distribution | ||
| A4ISOGXLNS3-REG | In distribution | ||
| A4ISOGXLNS-REG | 12 | In distribution | |
| CHMG53GNSM-REG | 10 | In distribution | |
| CHMG53GNS2XL-REG | 10 | In distribution | |
| CHMG53GNS800M-REG | 10 | In distribution | |
| CHMG53GNS800XL-REG | 10 | In distribution | |
| CHMG38GNSM-REG | 10 | In distribution | |
| CHMG38GNS8002XL-REG | 10 | In distribution | |
| CHMG38GNS800M-REG | 10 | In distribution | |
| A2ISOG2XLNS-REG | In distribution | ||
| GS0176 | Withdrawn | ||
| GS0401 | Withdrawn | ||
| GS0177 | Withdrawn | ||
| GS0178 | Withdrawn | ||
| A4ISOGXLNS-REG | Withdrawn | ||
| GS0809 | Withdrawn | ||
| GS0175 | Withdrawn | ||
| A4ISOGULNS-REG | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 230 |
| Henry Schein | Henry Schein, Inc. | 144 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 118 |
| Medline | Medline Industries, Inc. | 99 |
| Precaution/Isolation Gown | Standard Textile Co., Inc. | 83 |
| PremierPro | Prestige Ameritech | 74 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 71 |
| Medicom Safewear | AMD Medicom Inc. | 70 |
| Maytex | Maytex Corp. | 67 |
| Precept® | Precept Medical Products, Inc. | 61 |
| 3D Dental-Essentials | 3D Dental Designs AND Development, LLC | 56 |
| Halyard | O&M Halyard, Inc. | 53 |
Showing 12 of 230. All products under Non-Surgical Gown
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.